Work by UB, Amherst firm could expand area’s biotech industry

UB researchers find markers for disease

The most common symptoms are deceptively simple – dry eyes and a dry mouth. But the disorder is often dismissed or misdiagnosed until the condition leads to serious problems throughout the body that are difficult to treat.

Now, however, researchers at the University at Buffalo and IMMCO Diagnostics of Amherst say it may be possible to diagnose Sjogren’s earlier.

In a study in this month’s issue of the journal Clinical Immunology, the researchers reported finding new antibodies that can be tested for the presence of the disease. Antibodies are substances produced by the body’s immune system when it detects harmful substances.

UB has filed a patent on a potential biomarker-based method for detecting Sjogren’s, which affects an estimated 4 million people in the United States, and licensed the technology to IMMCO, which is developing a kit that medical laboratories may use to make the diagnosis.

A successful a test would add to IMMCO’s portfolio of diagnostic products and serve as another step forward for the region’s small but growing biotechnology industry.

“The tricky thing with Sjogren’s is that you usually only pick it up after it’s too late to do anything but treat the symptoms,” said Dr. Julian L. Ambrus Jr., a UB professor, immunologist at Buffalo General Medical Center and senior author of the paper.

Sjogren’s (pronounced SHOW-grins) syndrome is an autoimmune disease in which the body’s immune system attacks its own cells and tissue – in this case the glands that produce saliva and tears. It is named for the Swedish physician who first identified it.

Sjogren’s can lead to problems in other organs, such as the kidneys, digestive system, blood vessels, lungs, liver and the nervous system. Sufferers – nine out of 10 are women – are at higher risk of lymphoma, a cancer that begins in the immune system.

“The possibility of a new test is great news. Today, it takes six to 10 years to get a definitive diagnosis,” said Sharon Hoffman, a Sjogren’s patient in Rochester and the Western New York support group leader for the Sjogren’s Foundation.

Symptoms of Sjogren’s often mimic those seen in menopause and such conditions as lupus, a similar disorder, and multiple sclerosis. In about half of Sjogren’s cases, the disease occurs on its own, and in the other half, it overlaps other diseases, such as rheumatoid arthritis, according to the foundation. Symptoms can range in intensity from mild discomfort to serious impairment, and there is no cure.

“It’s a very complex disease with different things going on at different stages,” Ambrus said.

Currently, one method of diagnosing Sjogren’s is to look for one of two antibodies physicians refer to with the letters “Ro” and “La.” But about 40 percent of patients don’t have positive blood tests for these antibodies until late into the disease stages.

Ambrus and his colleagues found three new antibodies for Sjogren’s that can identify patients earlier and in those who lack the Ro and La antibodies. He said it’s not clear if the antibodies cause the syndrome.

“The assumption has been that you couldn’t do much for Sjogren’s,” Ambrus said. “Now, we may be able to find it at the right time and do something.”

A key development occurred when the researchers, through genetic modification, created mice for studies in which Sjogren’s acted exactly as it acts in humans, Ambrus said.

IMMCO, which specializes in products to diagnose autoimmune diseases, is now developing a kit that laboratories could use to diagnose Sjogren’s using the new biomarkers.

The company is seeking clearance from the Food and Drug Administration through the 510(k) medical device approval process for the kit. Plans are to sell the kit first in other countries in 2013, where the approval process is quicker and, until FDA device approval, offer Sjogren’s diagnosis using the new biomarkers as a service in the U.S. in which IMMCO will receive blood samples from hospitals and specialists, said William Maggio, IMMCO’s chief executive officer.

“This is a significant opportunity for us. Sjogren’s is one of the most undiagnosed diseases, and we feel we have a better solution for its diagnosis,” Maggio said.

As a laboratory service, the new test requires validation by the state Health Department, a step expected to occur early next year, officials said. FDA approval could take about 20 months, Maggio said.

The research received funding from the National Institutes of Health and UB’s Center for Advanced Biomedical and Bioengineering Technology.